Amlodipine & Valsartan Tablets USP

What is Amlodipine & Valsartan Tablets USP?

Amlodipine & Valsartan Tablets USP are a combination antihypertensive formulation containing amlodipine, a calcium channel blocker, and valsartan, an angiotensin II receptor blocker (ARB). Available in three specified strengths, the tablets are used for the management of hypertension when combination therapy is clinically appropriate.

Uses / Indications

Amlodipine and valsartan tablets may be used in the management of:

• Hypertension (high blood pressure)
• Hypertension requiring combination therapy when treatment with a single antihypertensive medicine is insufficient
• Patients who may require complementary blood-pressure-lowering effects from a calcium channel blocker and an angiotensin II receptor blocker

The specific strength and treatment regimen should be determined according to the patient’s clinical condition and approved product information.

Benefits

• Combines two antihypertensive agents with complementary mechanisms of action.
• Amlodipine helps relax and widen blood vessels by reducing calcium-dependent contraction of vascular smooth muscle.
• Valsartan blocks the effects of angiotensin II, helping reduce vasoconstriction and aldosterone-related effects.
• The combination provides an oral treatment option for patients requiring two antihypertensive mechanisms.
• Available in multiple strengths to support different prescribed treatment requirements.

Side Effects

Common Side Effects

Possible side effects may include:

• Headache
• Dizziness
• Peripheral oedema, particularly swelling of the ankles or feet
• Flushing
• Fatigue
• Palpitations
• Nausea
• Abdominal discomfort

Less Common or Serious Side Effects

Clinically important reactions may include:

• Excessive reduction in blood pressure
• Significant dizziness or fainting
• Changes in kidney function
• Increased blood potassium levels
• Angioedema or other hypersensitivity reactions
• Liver-related abnormalities
• Significant or persistent swelling

Medical attention should be sought if severe allergic reactions, fainting, marked weakness, breathing difficulty, or significant swelling of the face, lips, tongue or throat occurs.

How Does It Work?

Amlodipine

Amlodipine is a dihydropyridine calcium channel blocker. It inhibits the entry of calcium into vascular smooth muscle cells, producing relaxation of peripheral arterial blood vessels and reducing peripheral vascular resistance.

Valsartan

Valsartan is an angiotensin II receptor blocker (ARB). It selectively blocks the action of angiotensin II at the AT1 receptor, reducing vasoconstriction and decreasing aldosterone-mediated effects that can contribute to increased blood pressure.

Combination Action

Amlodipine and valsartan lower blood pressure through complementary mechanisms. Amlodipine primarily reduces vascular resistance through arterial vasodilation, while valsartan inhibits the vasoconstrictor effects of the renin-angiotensin system.

Dosage Guidelines

The appropriate strength and dosing schedule depend on the patient’s blood pressure, previous antihypertensive treatment, clinical response, kidney function, liver function, age, and other medicines being taken.

The available strengths are:

• Amlodipine 5 mg + Valsartan 160 mg
• Amlodipine 5 mg + Valsartan 320 mg
• Amlodipine 10 mg + Valsartan 160 mg

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For tablets:

• Take exactly as prescribed.
• Swallow the tablet with sufficient water unless otherwise directed.
• Follow the prescribed treatment schedule.
• Do not crush, split, chew or dissolve the tablet unless permitted by the approved product information.

When Not to Use

Amlodipine and valsartan tablets should not be used in patients with:

• Known hypersensitivity to amlodipine, valsartan, or any component of the formulation
• Pregnancy, particularly after pregnancy has been established, because medicines acting directly on the renin-angiotensin system can cause fetal harm

Particular medical assessment is required in patients with severe hepatic impairment, significant renal impairment, volume depletion, or conditions that may increase the risk of excessive hypotension.

Valsartan-containing treatment should not be combined with aliskiren in patients with diabetes.

Drug / Product Interactions

Clinically relevant interactions may occur with:

• Other antihypertensive medicines that may further reduce blood pressure
• ACE inhibitors or other medicines affecting the renin-angiotensin system
• Aliskiren
• Potassium supplements and potassium-containing salt substitutes
• Potassium-sparing diuretics
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Lithium
• Medicines that may affect kidney function
• Strong CYP3A4 inhibitors, which may increase amlodipine exposure

Patients taking multiple medicines should inform their healthcare professional before starting treatment.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Missed Dose

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose unless specifically instructed by a healthcare professional.

Driving

Dizziness, headache, fatigue or a reduction in blood pressure may affect the ability to drive or operate machinery in some patients. Patients should understand how the medicine affects them before performing such activities.

Alcohol

Alcohol may contribute to dizziness or an additional reduction in blood pressure. Patients should discuss alcohol consumption with a healthcare professional.

Pregnancy

Valsartan should not be used during pregnancy because medicines acting on the renin-angiotensin system may cause fetal injury. Patients who become pregnant while receiving treatment should promptly seek medical advice.

Breastfeeding

The use of the combination during breastfeeding should be discussed with a qualified healthcare professional, who can assess the individual benefits and risks.

Children

Use in children and adolescents should follow the approved product information and appropriate healthcare professional assessment.

Elderly Patients

Older patients may be more susceptible to blood-pressure reduction, dizziness and changes in kidney function. Appropriate clinical monitoring may be required.

Renal Impairment

Patients with impaired renal function require appropriate assessment and monitoring. Kidney function and serum potassium may require monitoring, particularly in patients receiving medicines that affect the renin-angiotensin system.

Hepatic Impairment

Caution and appropriate clinical assessment may be required in patients with hepatic impairment, particularly because amlodipine is extensively metabolised by the liver and valsartan exposure may also be affected by hepatic disease.

General Instructions

• Take the medicine according to the prescribed schedule.
• Swallow the tablet with sufficient water unless otherwise directed.
• Do not alter the dosage without professional advice.
• Follow the approved product information and healthcare professional’s instructions.
• Monitor blood pressure as recommended by the healthcare professional.
• Keep the medicine in its original packaging where appropriate.
• Do not share prescription medicines with other people.

Special Dietary / Lifestyle Tips

No specific dietary restriction is generally required unless advised by a healthcare professional.

Patients being treated for hypertension may be advised by their healthcare professional to maintain an appropriate diet, regular physical activity and other blood-pressure management measures.

Comparison with Other Treatments

Amlodipine and valsartan tablets are a fixed-dose combination of a calcium channel blocker and an angiotensin II receptor blocker.

Compared with single-agent therapy, combination treatment uses two complementary antihypertensive mechanisms. Other antihypertensive combinations may contain different drug classes, such as ACE inhibitors, diuretics or beta-blockers.

The choice of treatment depends on factors such as blood-pressure level, previous therapy, concomitant medical conditions, kidney and liver function, tolerability and the approved indication.

Precautions & Warnings

• Confirm any history of hypersensitivity to amlodipine, valsartan or related medicines.
• Do not use valsartan-containing treatment during pregnancy.
• Monitor blood pressure to avoid excessive hypotension.
• Use with caution in patients who are volume depleted or have significant dehydration.
• Appropriate monitoring may be required in patients with renal impairment.
• Serum potassium and kidney function may require monitoring in patients receiving valsartan, particularly when used with other medicines affecting potassium or renal function.
• Use cautiously in patients with hepatic impairment.
• Patients with heart failure or significant cardiovascular disease should receive appropriate medical assessment.
• Inform the healthcare professional about all concomitant medicines, including NSAIDs, potassium supplements and other antihypertensives.
• Seek medical attention for symptoms of angioedema such as swelling of the face, lips, tongue or throat.
• Do not discontinue prescribed antihypertensive treatment without professional advice.

Can I Use It With Other Medicines?

Generally Compatible With

Amlodipine and valsartan may be used with other medicines when clinically appropriate and under professional supervision. The complete medication profile should be reviewed before treatment.

Use With Caution / Avoid

Particular caution may be required with:

• Other medicines that lower blood pressure
• ACE inhibitors or other renin-angiotensin system medicines
• Aliskiren
• Potassium supplements or potassium-sparing medicines
• NSAIDs
• Lithium
• Medicines affecting kidney function
• Strong CYP3A4 inhibitors

Do not start, stop or change other medicines without appropriate medical advice.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• Keep out of reach of children.
• Do not use after the expiry date.
• Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What are Amlodipine & Valsartan Tablets used for?

Amlodipine and valsartan tablets are used for the management of hypertension. They combine two antihypertensive medicines with complementary mechanisms of action.

2. What are the available strengths?

The specified strengths are:

• Amlodipine 5 mg + Valsartan 160 mg
• Amlodipine 5 mg + Valsartan 320 mg
• Amlodipine 10 mg + Valsartan 160 mg

3. How do Amlodipine and Valsartan work?

Amlodipine reduces calcium-dependent contraction of vascular smooth muscle, promoting arterial vasodilation. Valsartan blocks angiotensin II at the AT1 receptor, reducing vasoconstriction and related effects that can increase blood pressure.

4. How should Amlodipine & Valsartan Tablets be taken?

The tablets should be taken exactly as prescribed by a healthcare professional and swallowed with sufficient water unless otherwise directed.

5. Can Amlodipine & Valsartan Tablets be used during pregnancy?

Valsartan should not be used during pregnancy because medicines acting on the renin-angiotensin system can cause fetal harm. Anyone who becomes pregnant while taking this medicine should promptly consult a healthcare professional.

6. Can these tablets be taken with other medicines?

They can interact with several medicines, including other antihypertensives, potassium-increasing medicines, NSAIDs, lithium and certain medicines that affect amlodipine metabolism. A healthcare professional should review the patient’s medicines before use.

7. What should I do if I miss a dose?

Take the missed dose when remembered unless it is nearly time for the next scheduled dose. If the next dose is due soon, skip the missed dose and continue with the regular schedule. Do not double the next dose unless specifically advised by a healthcare professional.

8. How should Amlodipine & Valsartan Tablets be stored?

Store the product according to the conditions stated on the approved product label and package insert, and keep it out of reach of children.